Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
FRONTEDGE
IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
1 other identifier
observational
315
1 country
28
Brief Summary
This observational study aims to collect data in clinical practice on the clinical profile of patients treated with Tezepelumab from Q1 2024 to Q1 2025 according to the approved and reimbursed indication in Italy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 20, 2026
April 1, 2026
1.9 years
April 9, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Demographic and Clinic characterization
To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab
Basal
COMORBIDITIES AND RELEVANT MEDICAL HISTORY
To describe the respiratory and non-respiratory related conditions in patients with severe asthma who initiated treatment with tezepelumab
Basal
Secondary Outcomes (13)
Exacerbation rate
Basal, 12 months, 24 months
mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use
Basal, 12 months, 24 months
ACT (Asthma Control Test) score
Basal, 12 months, 24 months
Asthma Control Questionnaire (ACQ) score
Basal, 12 months, 24 months
Lung function FEV1 (L)
Basal, 12 months, 24 months
- +8 more secondary outcomes
Other Outcomes (11)
Demographics and clinic characterization_clinic remission
12 months, 24 months
HCRU - number of specialistic visits for asthma
Basal, 12 months, 24 months
HCRU - number of hospitalization
Basal, 12 months, 24 months
- +8 more other outcomes
Study Arms (1)
Severe uncontrolled asthma patients
Adolescent and adult patients with severe uncontrolled asthma treated with tezepelumab will be enrolled in the study. Patients can be enrolled if they received at least one dose of tezepelumab either within the sampling program or as per routine clinical practice between February 2024 and March 2025.
Interventions
Tezepelumab is indicated as an add-on maintenance treatment in adult and adolescent ≥12 years patients with severe uncontrolled asthma despite high-dose inhaled corticosteroids plus long-acting β-agonists
Eligibility Criteria
Adolescent and adult patients with severe uncontrolled asthma treated with at least one dose of tezepelumab between February 2024 and March 2025 will be enrolled in the study.
You may qualify if:
- Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab);
- Patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ERS-ATS or GINA guidelines) requiring a stable treatment of high doses of ICS and a long acting β2 agonist ± additional asthma controller;
- Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications;
- Patients who signed the ICF and privacy form.
- Patients with continuous enrolment in the data source for at least 12-months before the index date.
- Patients with at least three months of continuous enrolment in the data source after the index date.
You may not qualify if:
- Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
- Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date.
- Patients who, during the observation period, participated in studies imposing a specific patient's management strategy, which does not correspond to the site's normal clinical practice.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (28)
Research Site
Cittadella (PD), Padova, Italy
Research Site
Montebelluna (TV), TV, Italy
Research Site
Aosta, Italy
Research Site
Avellino, Italy
Research Site
Bari, Italy
Research Site
Bergamo, Italy
Research Site
Brescia, Italy
Research Site
Cagliari, Italy
Research Site
Catania, Italy
Research Site
Catanzaro, Italy
Research Site
Civitanova Marche, Italy
Research Site
Ferrara, Italy
Research Site
Foggia, Italy
Research Site
Garbagnate(MI), Italy
Research Site
Genova, Italy
Research Site
Lamezia Terme, Italy
Research Site
Massa Carrara, Italy
Research Site
Milan, Italy
Research Site
Modena, Italy
Research Site
Naples, Italy
Research Site
Orbassano (TO), Italy
Research Site
Padova, Italy
Research Site
Reggio Emilia, Italy
Research Site
Roma, Italy
Research Site
Sassari, Italy
Research Site
Torino, Italy
Research Site
Tradate (VA), Italy
Research Site
Verona, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 29, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.